title: Efficacy of Gastrosis No.1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: a multi-center, double-blind, placebo-controlled clinical trial.
abstract: OBJECTIVE
  To assess the efficacy and safety of Gastrosis No.1 compound in the treatment of functional dyspepsia with Spleen (Pi) and Stomach (Wei) deficiency-cold syndrome.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled trial was performed in 5 centers. Patients with functional dyspepsia (FD) of Spleen-deficiency and qi-stagnation syndrome (162 cases) were randomly assigned to groups given Chinese herbal medicine (CHM) Gastrosis No.1 compound or placebo in a 2:1 ratio. This trial included a 4-week treatment period and a 4-week follow-up period. The outcomes were the dyspepsia symptom scores (measured by total dyspepsia symptom scale and single dyspepsia symptom scale) and syndromes of traditional Chinese medicine score (measured by traditional Chinese medicine syndrome scale). The outcomes were noted at weeks 0, 4 and 8.
  
  
  RESULTS
  Compared with patients in the placebo group, patients in the CHM group showed significant improvement in the dyspepsia symptom scores as rated by patients and investigators (P <0.01), and also showed improvement in syndromes of traditional Chinese medicine score (P <0.01). No serious adverse event was reported. Safety tests obtained after 4 weeks of treatment showed no abnormal values.
  
  
  CONCLUSIONS
  CHM Gastrosis No.1 compound was effective and safe in the treatment of functional dyspepsia with Spleen and Stomach deficiency-cold syndrome.
authors.affiliation: Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010, China. zhss2000@163.com
authors.forename: Sheng-Sheng
authors.initials: SS
authors.lastname: Zhang
authors.forename: Lu-Qing
authors.initials: LQ
authors.lastname: Zhao
authors.forename: Hong-Bing
authors.initials: HB
authors.lastname: Wang
authors.forename: Bing
authors.initials: B
authors.lastname: Wu
authors.forename: Chui-Jie
authors.initials: CJ
authors.lastname: Wang
authors.forename: Sui-Ping
authors.initials: SP
authors.lastname: Huang
authors.forename: Hong
authors.initials: H
authors.lastname: Shen
authors.forename: Wei
authors.initials: W
authors.lastname: Wei
authors.forename: Yao-Liang
authors.initials: YL
authors.lastname: Lai
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004415:Dyspepsia / Q000188:drug therapy* / Q000503:physiopathology*; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D013154:Spleen / Q000187:drug effects / Q000503:physiopathology*; D013270:Stomach / Q000187:drug effects / Q000503:physiopathology*; D013577:Syndrome; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D010919:Placebos; C588021:gastrosis no. 1